Fat Reduction and Muscle Toning of Thighs
- Conditions
- Fat Burn
- Interventions
- Device: BTL-899
- Registration Number
- NCT04599257
- Lead Sponsor
- BTL Industries Ltd.
- Brief Summary
This study will evaluate the clinical efficacy and safety of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for changes in subcutaneous fat tissue and muscle toning of thighs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- Age > 21 years
- Voluntarily signed an informed consent form
- BMI ≤ 35 kg/m2
- Women of child-bearing potential are required to use birth control measures during the whole duration of the study
- Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
- Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation
- Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- Metal implants
- Drug pumps
- Malignant tumor
- Pulmonary insufficiency
- Injured or otherwise impaired muscles
- Cardiovascular diseases
- Disturbance of temperature or pain perception
- Hemorrhagic conditions
- Septic conditions and empyema
- Acute inflammations
- Systemic or local infection such as osteomyelitis and tuberculosis
- Contagious skin disease
- Elevated body temperature
- Pregnancy, postpartum period, nursing, and menstruation
- Intrauterine device (IUD)
- Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area
- Basedow's disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hip and thigh circumference changes BTL-899 The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device. At the baseline visit, MRI imaging will be performed; the subject's weight and hip and thigh circumference will be recorded. Photos of the treated area will be taken. The treatment administration phase will consist of four (4) treatments, delivered once a week. The applicator of the device will be applied over the treatment area. The device will induce visible muscle contractions along with heating of the subcutaneous fat. At the last therapy visit, the subject's weight and hip and thigh circumference will be recorded, and photos of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire to fill in.
- Primary Outcome Measures
Name Time Method Evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging 7 months The primary objective of the study is to determine the effectiveness of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for change in the adipose layer thickness between pre-treatment and post-treatment based on MRI imaging. The changes will be considered statistically significant where p-value \<0.05.
- Secondary Outcome Measures
Name Time Method Assess safety profile by recording of adverse events 7 months All AEs including local and systemic reactions not meeting the criteria for "serious adverse events" will be captured on the appropriate CRF. Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed only by those with the training and authority to make a diagnosis, which would include MD, DDS, DMD, PA, Nurse Practitioner or DO), and time of resolution/stabilization of the event. All AEs occurring during the study must be documented appropriately regardless of relationship to study device. All AEs will be followed to adequate resolution.
Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire 7 months The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome. Subject satisfaction will be assessed after the last therapy visit and during the follow-up visits with 4-therapy related questions with answer "Strongly agree" will be the best possible answer and "Strongly disagree" the worst.
Trial Locations
- Locations (4)
Brian M. Kinney M.D., Inc
🇺🇸Beverly Hills, California, United States
Art of Skin MD
🇺🇸Solana Beach, California, United States
Yael Halaas, M.D., F.A.C.S.
🇺🇸New York, New York, United States
Center For SmartLipo & Plastic Surgery
🇺🇸Langhorne, Pennsylvania, United States